I had a chance to catch up with Steve who is a consultant and project lead engineer in the Life Sciences industry organization to understand what experience they shared with those who attended their presentation.

Steve shared five strategies for helping to reduce risk in projects. These include:

Set Expectations

Prototype

Establish Project Guidelines

Use Global Standards

Leverage Testing

Set Expectations. Risks in miscommunication, budget, schedule, and overall project execution can be reduced by having the project team (both manufacturer and supplier(s)) align on the expectations for the project. The expectations include the deliverables, documentation, schedule, procedures and processes, tracking metrics, and the overall level of automation and integration between systems and processes. This helps aim everyone’s efforts in the same direction and discovers efficiencies which can be gained as the project is implemented.

Prototype. Risks in budget, schedule, changes, and project execution can be reduced with a prototyping strategy. Prototyping helps incorporate operational philosophies into the upfront engineering, helps ensure consistent look and feel, and provides a visual medium to communicate designs to the project team, manufacturing, maintenance, and other interested parties. The prototype lays the foundation for the project guidelines and demonstrates methods for software testing, operator training, and process simulation. This strategy can reduce changes later in the project. There is much more to say on what and how to prototype which I’ll save for a future post.

Establish Project Guidelines. Risks in budget, schedule, maintainability, and project execution can be reduced by establishing clear project guidelines. The agreement of established procedures, practices, and fundamental philosophies at the front of a project help avoid project-wide changes later in the project. These guidelines should cover execution methodology, change control, document control, testing and all the team member roles and responsibilities. It covers all aspects of the automation project including operator interface, batch architecture, continuous control, devices and I/O, and integration with external systems.

Use Global Standards. Risks in budget, schedule, maintainability, and training can be reduced by establishing or using already established global standards. Global standards in this context refer to standard, modular, pre-tested pieces of automation like control modules, equipment modules, phases, etc. These standards incorporate existing knowledge and best practices, help facilitate communication between team members, and shorten the learning curve for new members to the project team. Ongoing maintenance and support is easier for the 80-90% of the project configuration that typically can use global standards. These standards are often provided by automation suppliers since they see more projects and can more efficiently iterate towards an ideal standard. In addition, spreading the development costs across a broad project base can significantly reduce these costs.

Leverage Testing. Like using global standards, risks in budget, schedule, maintainability, and training can be reduced by leveraging good testing practices. For highly regulated Life Science manufacturers, everything needs to be tested and documented. The key is that each level of testing (supplier, acceptance, commissioning, IQ, OQ, PQ) should build on the previous layer and not repeat it. Testing is always a risk-based endeavor.

There can never be so much as to eliminate every possible problem scenario. At some point the cost can drive a project cost more than anything else. It’s better to spread testing cost for standard items as widely as possible, and load most of the testing into the front end of a project since testing gets progressively more expensive the further it is done in a project schedule. The key is a solid test plan which identifies the risk areas from all members of the project team and finding ways to combine some of the testing levels like commissioning and qualification.

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